Navigation Links
FDAnews Announces — New Book — Guide to FDA and EU Medical Device Regulations: 2017 Edition
Date:6/28/2017

Guide to FDA and EU Medical Device Regulations: 2017 Edition
**An FDAnews Book**
http://www.fdanews.com/fdaeumdregs    

No matter on which side of the Atlantic devicemakers do business, this fully updated and expanded guide keeps them in touch with the medical device regulations they have to follow.

In addition to the full text of the FDA’s regulations in 21 CFR Parts 800 to 898, the 2017 Guide includes more than 150 FDA guidances for devicemakers, covering everything from acceptance and filing review of premarket approval applications to the unique device identification system.

The FDA has released more than 50 new guidances since publication of the 2015 Guide, including:

  • List of Highest Priority Devices for Human Factors Review
  • Reporting of Computational Modeling Studies in Medical Device Submissions
  • Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
  • Software as a Medical Device (SaMD): Clinical Evaluation
  • Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  • FY 2017 Medical Device User Fee Small Business Qualification and Certification
  • Adaptive Designs for Medical Device Clinical Studies

Readers will find them all here.

Plus, readers will get the full text (more than 1,000 pages) of the European Union’s newly revised regulations for medical devices and in vitro diagnostic devices.

Published in PDF format, readers will be able to perform keyword searches on the entire (5,000+ pages) Guide as well as pick and choose the documents they need to reference and even print and disseminate them to their staff.

For newcomers and veterans alike, this is a must-have quick-reference encyclopedia.

Stay up-to-date on key medical device regulations with Guide to FDA and EU Medical Device Regulations, 2017 edition, the most authoritative and comprehensive guide ever assembled.

FDAnews Book Details:
Guide to FDA and EU Medical Device Regulations: 2017 Edition
Price: $397
http://www.fdanews.com/fdaeumdregs    

Easy Ways to Order:
Online:     http://www.fdanews.com/fdaeumdregs            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/guidefdaeumdregs/prweb14468608.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Announces — Disinfectant Testing and Validation Webinar, June 29, 2017
2. FDAnews Database — Limited Time Offer Save $500 on 483sOnline.com
3. FDAnews Announces — Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny Webinar, June 27, 2017
4. FDAnews Announces — Medical Device Premarket Regulatory Pathways: Maximizing Efficiency—Saving Time, Money & Resources Webinar, June 7, 2017
5. FDAnews Announces — Brexit and Life Sciences Companies Webinar, May 31, 2017
6. FDAnews Announces: Understanding and Implementing EU Medical Device Regulation Workshop, July 11-12, 2017
7. FDAnews Announces — GMP Human Error Reduction Program: The Keys to Increased Performance, June 29-30, 2017, Arlington, VA
8. FDAnews Announces — Supplier Contracts for Non-Lawyers: What Really Needs to be in Your Agreements Webinar, May 23, 2017
9. FDAnews Announces: Medical Device Supplier Quality Management: Are You and Your Suppliers Compliant?, June 21-22, 2017, Arlington, VA
10. FDAnews Announces — The FDA Under a New Commissioner Webinar, May 17, 2017
11. FDAnews Announces: Combination Products Regulation, Policy & Best Practices: It’s a Whole New Ballgame — Are You All In?, June 8, 2017
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/14/2019)... N.H. (PRWEB) , ... August 13, 2019 , ... New ... the heart-healthy antioxidant resveratrol, today announced an expansion of its line of CBD-infused coffees ... 300 mg of CBD in a 12-oz bag. , “We are excited to ...
(Date:8/14/2019)... ... ... In a recent Trivedi Effect workshop, Master Dahryn Trivedi spoke about the path ... obliterate your old beliefs,” said Master Dahryn. “Doubt helps you look at your belief ... your awareness. Trust that the Divine has put you here for a purpose.” ...
(Date:8/14/2019)... ... ... While it is commonly understood that good nutrition promotes general health, consumers are ... and, in some cases, reverse certain medical conditions, according to health and wellness research ... trying to manage a health or medical condition by making healthy food and beverage ...
(Date:8/12/2019)... (PRWEB) , ... August 12, 2019 , ... Eco ... Boulevard #315 in Pembroke Pines, Florida 33027. For over 25 years, Eco Pump Services ... and septic tank pumping services . Eco Pump’s steady five-star ratings and ...
(Date:8/12/2019)... (PRWEB) , ... August 12, 2019 , ... Parents craving ... not only nourish their families but also help feed children in need. IsaKids® Super ... Celebration 2019 event in Nashville, Tennessee. The global health and wellness company also debuted ...
Breaking Medicine News(10 mins):
(Date:8/12/2019)... (PRWEB) , ... August 12, 2019 , ... Intalere, the ... has been named as a finalist in the Innovator of The Year - Health ... are honored to be recognized by the Pittsburgh Technology Center as a healthcare IT ...
(Date:8/10/2019)... ... August 10, 2019 , ... ... outpatient programs. Educating parents to obtain mental health screenings for early onset of ... shootings and provided a solution to the community with free assessment reviews. At ...
(Date:8/9/2019)... ANGELES (PRWEB) , ... August 09, 2019 , ... ... an exclusive interview with Anpac Bio CEO Dr. Chris Yu to discuss their ... an up-and-coming international cancer screening company that has developed a novel technology based ...
Breaking Medicine Technology: